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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041422
Receipt No. R000047291
Scientific Title A histological cohort study to assess the safety and effectiveness of olaparib monotherapy in patients with platinum-sensitive relapsed ovarian cancer
Date of disclosure of the study information 2020/10/27
Last modified on 2021/08/30

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Basic information
Public title A historical cohort study to assess the safety and effectiveness of olaparib monotherapy in patients with platinum-sensitive relapsed ovarian cancer
Acronym JGOG3026 RESPONSE study
Scientific Title A histological cohort study to assess the safety and effectiveness of olaparib monotherapy in patients with platinum-sensitive relapsed ovarian cancer
Scientific Title:Acronym JGOG3026 RESPONSE study
Region
Japan

Condition
Condition Ovarian cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the safety and effectiveness of olaparib monotherapy in patients with platinum-sensitive relapsed ovarian cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of adverse events during olaparib monotherapy in patients with platinum-sensitive relapsed ovarian cancer
Key secondary outcomes Progression-free survival (PFS), PFS2, TFST, and OS in patients with platinum-sensitive relapsed ovarian cancer who received olaparib monotherapy.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria All patients with platinum-sensitive relapsed ovarian cancer who received olaparib monotherapy from January 2018 to July 2020.
Key exclusion criteria 1. platinum-resistant relapsed ovarian cancer
2. stable or progressive disease after platinum-based chemotherapy for patients with platinum-sensitive relapsed ovarian cancer
3. patients who had already received a PARP inhibitor before recurrence
4. patients who received both olaparib and bevacizumab combination maintenance therapy.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Tayuki
Middle name
Last name Enomoto
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Obstetrics and Gynecology
Zip code 951-8510
Address 1-757, Asahimachi-dori, Chuo-ku, Niigata, Niigata, 951-8510, Japan
TEL 025-227-2320
Email enomoto@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name Kosuke
Middle name
Last name Yoshihara
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Obstetrics and Gynecology
Zip code 951-8510
Address 1-757, Asahimachi-dori, Chuo-ku, Niigata, Niigata, 951-8510, Japan
TEL 025-227-2320
Homepage URL
Email yoshikou@med.niigata-u.ac.jp

Sponsor
Institute Japanese Gynecologic Oncology Group (JGOG)
Institute
Department

Funding Source
Organization Japanese Gynecologic Oncology Group (JGOG)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Japanese Gynecologic Oncology Group
Address 4F, Komatsu Building, 6-22, Kagurazaka, Shinjuku-ku, Tokyo, 162-0825, Japan
Tel 03-5206-1982
Email info@jgog.gr.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 10 Month 27 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2020 Year 08 Month 05 Day
Date of IRB
2020 Year 09 Month 24 Day
Anticipated trial start date
2020 Year 11 Month 01 Day
Last follow-up date
2023 Year 08 Month 31 Day
Date of closure to data entry
2023 Year 08 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information Adverse events and prognosis in patients with platinum-sensitive relapsed ovarian cancer who received olaparib monotherapy

Management information
Registered date
2020 Year 08 Month 14 Day
Last modified on
2021 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047291

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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